U.S. patent application number 16/235624 was filed with the patent office on 2020-07-02 for catheter with vessel lining for cell collection and methods for using same.
The applicant listed for this patent is Cruzar Medsystems, Inc.. Invention is credited to Albert K. Chin, Michael Glennon.
Application Number | 20200205795 16/235624 |
Document ID | / |
Family ID | 71122394 |
Filed Date | 2020-07-02 |
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United States Patent
Application |
20200205795 |
Kind Code |
A1 |
Chin; Albert K. ; et
al. |
July 2, 2020 |
Catheter with Vessel Lining for Cell Collection and Methods for
Using Same
Abstract
A system and method for cell collection within a vessel. The
system including a cannula having a pathway extending from a first
end to a second end, a elongated member situated longitudinally
within the pathway of the cannula, a sleeve coupled to the second
end of the cannula and a balloon situated within the sleeve.
Inventors: |
Chin; Albert K.; (Palo Alto,
CA) ; Glennon; Michael; (Norwell, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cruzar Medsystems, Inc. |
Braintree |
MA |
US |
|
|
Family ID: |
71122394 |
Appl. No.: |
16/235624 |
Filed: |
December 28, 2018 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2025/1065 20130101;
A61B 10/04 20130101; A61M 2025/0004 20130101 |
International
Class: |
A61B 10/04 20060101
A61B010/04 |
Claims
1. A system for cell collection within a vessel, the system
comprising: a cannula having a pathway extending between a first
end and a second end of the cannula; an elongated member situated
longitudinally within the pathway of the cannula, and having a
distal end; an inverted balloon situated within the cannula and
being coupled at one end of the distal end of the elongated member
and coupled at an opposing end of the second end of the cannula to
permit eversion of the balloon when the elongated member is
advanced; and an inverted sleeve situated within the balloon and
being attached at one end adjacent to the second end of the
cannula, such that upon eversion of the balloon from the cannula,
the sleeve is also everted.
2. The system of claim 1, wherein the elongated member includes a
conduit along its length to permit a device to extend along the
length of the elongated member.
3. The system of claim 1, wherein the balloon is in fluid
communication with the pathway and configured to receive
pressurizing fluid from the pathway for eversion out from the
second end of the cannula.
3. The system of claim 1, wherein the sleeve is configured to evert
from the second end of the cannula upon pressurization of the
balloon.
4. The system of claim 1, wherein the sleeve is sufficiently longer
than the balloon such that the sleeve is partially everted from the
cannula when the balloon is fully everted from the cannula.
5. The system of claim 1, wherein the sleeve is sufficiently
shorter than the balloon such that the sleeve is fully everted from
the cannula when the balloon is fully everted from the cannula.
6. The system of claim 1, wherein a surface on a second portion of
the sleeve includes at least one of a textured surface, an adhesive
surface, and an open mesh surface.
7. The system of claim 1, wherein the cannula is sufficiently
flexible to be advanced through a vessel in a body.
8. The system of claim 1, wherein the balloon has a diameter
sufficiently large to press the sleeve against the inner walls of a
body structure for cell collection.
9. The system of claim 1, further comprising a fluid tight seal
configured to provide frictional force between the cannula and the
elongated member.
10. The system of claim 1, further comprising an inflation port in
fluid communication with the pathway of the cannula and the
balloon.
11. The system of claim 1, wherein the elongated member is
configured to move longitudinally within the pathway of the
cannula.
12. The system of claim 1, further comprising a sheath axially
located about an exterior surface of the cannula.
13. A method for cell collection within a vessel, the method
comprising: placing a cannula within the vessel within a body, the
cannula comprising: a pathway extending between a first end and a
second end of the cannula; an elongated member situated
longitudinally within the pathway of the cannula, and having a
distal end; an inverted balloon situated within the cannula and
being coupled at one end of the distal end of the elongated member
and coupled at an opposing end of the second end of the cannula;
and an inverted sleeve situated within the balloon and being
attached at one end adjacent to the second end of the cannula, such
that upon eversion of the balloon from the cannula, the sleeve is
also everted; everting at least a portion of the sleeve out the
second end of the cannula; initiating contact between a surface of
the sleeve and a sidewall of the vessel; and collecting sample
cells on the surface of the sleeve.
14. The method of claim 13, further comprising pressurizing the
balloon by inputting fluid into the pathway.
15. The method of claim 14, further comprising everting the
pressurized balloon by pushing the elongated member longitudinally
toward the second end of the cannula.
16. The method of claim 15, wherein the at least the portion of the
sleeve is everted by the everting balloon.
17. The method of claim 16, wherein the sleeve is partially everted
from the pathway of the cannula.
18. The method of claim 17, further comprising reinverting the
sleeve within the pathway of the cannula.
19. The method of claim 16, wherein the sleeve is fully everted
from the pathway of the cannula.
20. The method of claim 19, further comprising depressurizing the
balloon and positioning a sheath over the sleeve.
Description
BACKGROUND
[0001] Taking all samples from within body cavities and vessels can
be used for pretreatment diagnosis. Typically, samples can be
collected during endoscopic procedures using a combination of tools
including needles, forceps, etc. These systems and tools, however,
can require significant skill to target and collect a sample, and
in some instances, can cause damage to the targeted tissue.
Accordingly, it would be desirable to have a system that can safely
and easily obtain cell samples from targeted tissue.
SUMMARY OF THE INVENTION
[0002] In some embodiments, a system for cell collection within a
vessel is provided. The system can include a cannula having a
pathway extending between a first end and a second end of the
cannula, an elongated member situated longitudinally within the
pathway of the cannula, and having a distal end, an inverted
balloon situated within the cannula and being coupled at one end of
the distal end of the elongated member and coupled at an opposing
end of the second end of the cannula to permit eversion of the
balloon when the elongated member is advanced, and an inverted
sleeve situated within the balloon and being attached at one end
adjacent to the second end of the cannula, such that upon eversion
of the balloon from the cannula, the sleeve is also everted.
[0003] In some embodiments, the elongated member can include a
conduit along its length to permit a device to extend along the
length of the elongated member. The balloon can be in fluid
communication with the pathway and configured to receive
pressurizing fluid from the pathway for eversion out from the
second end of the cannula. The sleeve can be configured to evert
from the second end of the cannula upon pressurization of the
balloon. The sleeve can be sufficiently longer than the balloon
such that the sleeve is partially everted from the cannula when the
balloon is fully everted from the cannula. The sleeve can be
sufficiently shorter than the balloon such that the sleeve is fully
everted from the cannula when the balloon is fully everted from the
cannula.
[0004] In some embodiments, a surface on a second portion of the
sleeve can include at least one of a textured surface, an adhesive
surface, and an open mesh surface. The cannula can be sufficiently
flexible to be advanced through a vessel in a body. The balloon can
have a diameter sufficiently large to press the sleeve against the
inner walls of a body structure for cell collection. The system can
further include a fluid tight seal configured to provide frictional
force between the cannula and the elongated member. The system can
further include an inflation port in fluid communication with the
pathway of the cannula and the balloon. The elongated member can be
configured to move longitudinally within the pathway of the
cannula. The system can further include a sheath axially located
about an exterior surface of the cannula.
[0005] In some embodiments, a method for cell collection within a
vessel is provided. The method can include placing a cannula within
the vessel within a body. The cannula can include a pathway
extending between a first end and a second end of the cannula, an
elongated member situated longitudinally within the pathway of the
cannula, and having a distal end, an inverted balloon situated
within the cannula and being coupled at one end of the distal end
of the elongated member and coupled at an opposing end of the
second end of the cannula, and an inverted sleeve situated within
the balloon and being attached at one end adjacent to the second
end of the cannula, such that upon eversion of the balloon from the
cannula, the sleeve is also everted. The method can also include
everting at least a portion of the sleeve out the second end of the
cannula, initiating contact between a surface of the sleeve and a
sidewall of the vessel, and collecting sample cells on the surface
of the sleeve.
[0006] In some embodiments, the method can further include
pressurizing the balloon by inputting fluid into the pathway. The
method can further include everting the pressurized balloon by
pushing the elongated member longitudinally toward the second end
of the cannula. The at least the portion of the can be is everted
by the everting balloon. The sleeve can be partially everted from
the pathway of the cannula. The method can further include
reinverting the sleeve within the pathway of the cannula. The
sleeve can be fully everted from the pathway of the cannula. The
method can further include depressurizing the balloon and
positioning a sheath over the sleeve.
BRIEF DESCRIPTION OF DRAWINGS
[0007] FIGS. 1, 2A, and 2B illustrate a system for collecting cell
samples, in accordance with an embodiment of the present
invention.
[0008] FIGS. 3A, 3B, 3C, and 3D illustrate a system for collecting
cell samples, in accordance with another embodiment of the present
invention.
[0009] FIGS. 4A, 4B, 4C, and 4D illustrate example textures for use
in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION
[0010] In accordance with various embodiments of the present
invention, systems and methods are provided for cell collection
within a body of an object, for instance, a human or animal. The
systems and methods described below may also, in some instances, be
used to collect cell samples from within vessels, including
arteries, veins, ureters, urethra, Fallopian tubes, pancreatic
ducts, nasal sinuses, or any luminal structures or cavities in the
body.
[0011] FIG. 1 depicts an example implementation of a system 100 in
accordance with the present invention. In some embodiments, the
system 100 can include a cannula 102 configured to house various
components of the system 100. The cannula 102 can include a
proximal end 104, a distal end 106, and a pathway 108 extending
therebetween. The pathway 108, in an embodiment, can extend
longitudinally through the entirety of the cannula 102. To the
extent desired, pathway 108 can extend along a portion of the
cannula 102. In some embodiments, the cannula 102 can include
openings at both ends of the pathway 108. The cannula 102 can have
any desired length, depending upon the application, so long as the
cannula 102 can be advanced through a vessel to a target site for
cell sampling. For example, in one embodiment, the cannula 102 may
be relatively long so that it can be advanced through a long or
tortuous vessel or body cavity to a target site for cell sampling.
In another embodiment, the cannula 102 may be a relatively short
for ease of maneuverability. The cannula 102 may also have any
diameter sufficient to allow the cannula 102 to fit within a
vessel, depending upon the application. In an embodiment, the
diameter of the cannula 102 may remain substantially constant
throughout. If desired, the diameter of the cannula 102 may vary,
as necessary, along the length of the cannula 102.
[0012] In some embodiments, since the cannula 102 is designed to be
inserted into vessels of a human or animal body, the cannula 102
can be sufficiently rigid in the longitudinal direction and
flexible in a radial direction to assist in navigating torturous
pathways. Similarly, the cannula 102 can be made from a material
that is biocompatible. The biocompatibility of the material may
help minimize occurrence of adverse reactions due to use of the
cannula 102 within a vessel. Examples of suitable materials include
various types of metals, plastics, or any other materials. In some
instances, cannula 102 may also be made from a bioabsorbable
material so that cannula 102 may remain in the body to be absorbed
by the body over time.
[0013] In some embodiments, the cannula 102 can include a sleeve
110 for use in collecting cell samples. In some embodiments, the
sleeve 110 can be coupled at one end 112 at the distal end 104 of
the cannula 102. For example, the sleeve 110 can be coupled to the
end of the cannula 102, adjacent to the end of the cannula 102,
and/or attached to the balloon 120 at the end of the cannula 102.
The sleeve 110 can be configured to extend from an inverted
position within the pathway 108 of the cannula 102 to an everted
position outside of the cannula 102, as discussed in greater detail
herein. The sleeve 110 can further include an opposing end 114, and
a pathway 116 between ends 112 and 114. In some embodiments, while
end 112 of the sleeve 110 can be coupled at the distal end 104 of
the cannula 102, end 114 of the sleeve 110 can be unattached and/or
open.
[0014] The sleeve 110, in some embodiments, can include any size
and shape designed to accommodate the components of the present
invention. For example, the sleeve 110 can be substantially tubular
in shape. In some embodiments, sleeve 110 may be sufficiently
flexible so that it can be everted outward from within the cannula
102 as so that it can navigate through a tortuous path in a vessel.
The sleeve 110 may also have any desired length, depending upon the
application, so long as sleeve 110 can be advanced from the cannula
102 to the target site for cell sampling. For example, in one
embodiment, sleeve 110 may be relatively long so that it can be
advanced through a long or tortuous vessel to a target site for
cell sampling. In another embodiment, the sleeve 110 may be a
relatively short sleeve for more control. The sleeve 110 may also
have any diameter sufficient to allow the sleeve 110 to fit within
a vessel or cavity of interest, depending upon the application and
the size of the vessel or cavity. In an embodiment, the diameter of
the sleeve 110 may remain substantially constant throughout. If
desired, the diameter of the sleeve 110 may vary, as necessary,
along the length of the sleeve 110.
[0015] In some embodiments, the sleeve 110 can include a coating on
its outer surface to assist in the collection of cells. In some
embodiments, the coating can reduce friction between the sleeve 110
and the tissue wall upon eversion while maintaining cell collecting
properties of the sleeve 110. In one embodiment, the coating may
cover the entire outer surface of the sleeve 110. In an alternative
embodiment, the coating may be locating only at the end 112 of the
sleeve 110 (e.g., the portions everting outside the cannula 102).
Of course, the coating may be placed onto the outer surface in
other manners as well. Likewise, the sleeve 110 may include a
coating on at least a portion of an inner surface of the sleeve 110
to reduce friction during eversion and reinversion. In one
embodiment, the inner coating may cover the entire inner surface of
the sleeve 110.
[0016] In some embodiments, portions of the sleeve 110 can be made
from different materials. For instance, in one embodiment, if
desired, only a portion of sleeve 110 may be made from a
substantially flexible material, for example the end 112, that
allows eversion, while the remainder of the sleeve 110 may be made
from a less flexible material to minimize deformation of the sleeve
110 during delivery through the vessel. For example, the sleeve 110
can be constructed of a very thin (e.g. 0.0001''-0.0003'' thick)
fibrous or fabric material. In some embodiments, the sleeve 110 can
contain a textured surface to promote adhesion of cells to its
surface. Examples of textured surfaces for collection can include a
surface that includes ribs, protrusions, nubs, grooves, scales,
peaks and valleys or any other designs known in the art that can
provide surface texture.
[0017] Alternatively, sleeve 110 can be provided with an adhesive
surface or, with openings, or with an open mesh design to enhance
cell collection when the sleeve 110 is in an everted position. In
some embodiments, only an outer surface and/or a portion of the
sleeve 110 may be provided with a cell collection surface. For
example, the outer portion of the end 112 of the sleeve 110 can
include cell collection surface(s). As would be appreciated by one
skilled in the art, any combination of textured surfaces for
capturing cells on a vessel wall could be utilized without
departing from the scope of the present invention.
[0018] Since the sleeve 110 is designed to be inserted into vessels
of a human or animal body, the sleeve 110 can be made from a
material that is biocompatible. The biocompatibility of the
material may help minimize occurrence of adverse reactions due to
use of the sleeve 110 within a vessel. Examples of suitable
materials include various types of polymers, plastics, or any other
similar materials.
[0019] As depicted in FIG. 1, in some embodiments, the system 100
of the present invention can include a balloon 120 situated between
an inner wall of the cannula 102 and the sleeve 110 to facilitate
eversion of the sleeve 110 from within the cannula 102. In some
embodiments, balloon 120 may be capable of exerting a compression
force on the end 114 of the sleeve 110 while exerting a pushing
force on the end 112 of the sleeve 110, so as to move the sleeve
110 from an inverted position to an everted position. In some
embodiments, a first end of the balloon 120 can be coupled at the
distal end 104 of the cannula 102 and/or the end 112 of the sleeve
110. In some embodiments, a second end of the balloon 120 can be
coupled to a distal end of an elongated member 118, discussed in
greater detail herein. As would be appreciated by one skilled in
the art, the balloon 120 can be coupled to the cannula 102 and
elongated member 118 using any means known in the art, so long as a
substantially fluid-tight seal is provided. As depicted in FIG. 1,
to evert the end 112 of the sleeve 110 for cell sampling, in some
embodiments, the balloon 120 may be positioned within sleeve 110
such that, as it is everted, it can push against and the end 112 of
the sleeve and evert the sleeve 110 either alone or in conjunction
with the use of the elongated member 118.
[0020] In some embodiments, the balloon 120 can include and/or
otherwise be in fluid communication with pathway 108 along which
balloon 120 can be pressurized. The pathway 108, as can be
appreciated, in some embodiments, a lumen (not shown) independent
of pathway 108 may be coupled to balloon 120 to pressurize the
balloon 120. The balloon 102, in some embodiments, can be
pressurized by way of an inflation mechanism (not shown), that is
in fluid communication with the cannula 102. The inflation
mechanism may be a pump (e.g. a manual or automatic pump), syringe,
or other device that can pressurize and/or depressurize the balloon
120 during use. In some embodiments, inflation mechanism may be
coupled to an inflation port 122, which may in turn be coupled to a
proximal end of cannula 102. Of course, other locations for the
inflation port 122 are possible as long as fluids can enter with a
sufficient force to deploy the balloon 120.
[0021] Since the balloon 120 is designed to be inserted into a
human or animal body, the balloon 120 can be made from a material
that is biocompatible. The biocompatibility of the material may
help minimize occurrence of adverse reactions due to use of the
balloon 120 within a vessel. Examples of suitable materials include
various types of polymers, plastics, or any other similar
materials. For example, the balloon 120 can be a high tensile
strength polymer such as polyethylene terephthalate (PET), that is
able to sustain high pressures (10-20 atm), allowing it to evert
itself plus the sleeve 110.
[0022] The balloon 120 can further be made from any material that
can aid in the eversion process. In one embodiment, the balloon 120
can be made from a material that minimizes resistance and friction
so as to evert and bypass the obstruction with greater ease. For
instance, the balloon 120 can be made from a material that is
substantially smooth and/or has a relatively low coefficient of
friction. Should it be desired, balloon 120 may further include a
coating that can aid in eversion, re-inversion, or any other
characteristic that may be desirable for the balloon 120. The
coating may be applied to the balloon 120 on an inner surface, an
outer surface, or a combination thereof.
[0023] The length of the balloon 120 may, in an embodiment, vary
depending on a variety of characteristics. In certain instances,
the length of the balloon 120 may be dependent on the length of the
cannula 102 and/or the size and shape of the vessel 126 from which
a tissue sample(s) is collected. In other instances, the length of
the balloon 120 may vary depending the length of sleeve 110.
[0024] Similarly, the balloon 120 may also have any diameter
desirable so long as the diameter allows the balloon 120 to fit the
cannula 102 or accommodate sleeve 110. In some instances, balloon
120 may have a diameter sufficiently large so that, when everted,
it can press sleeve 120 against the tissue wall of a vessel 126 for
sample collection. Additionally, by pressurizing against the tissue
wall of the vessel 126, the balloon 120 can prevent push-back
(e.g., into the cannula 102) when the balloon 120 and/or the sleeve
110 interacts objects within the vessel 126 or the body itself. In
one embodiment, the balloon 120 may have a diameter to allow the
balloon 120 to substantially conform to the vessel walls when in an
everted state. However, in the everted state, the diameter of the
balloon 120 may also be smaller than the diameter of the sleeve
110, to minimize the likelihood of rupturing the sleeve 110. Of
course, larger or smaller diameters may also be possible.
[0025] The balloon 120 may also have any shape desirable so long as
the shape allows the balloon 120 to fit within the cannula 102, and
to evert the sleeve 110 therefrom. In one embodiment, the balloon
120 may have a substantially tubular shape to allow the balloon 120
to substantially conform to the vessel 126. Of course, other
geometric shapes are also within the scope of the present
invention.
[0026] Continuing with FIG. 1, in some embodiments, the system 100
can include a elongated member 118 that can be slidably engaged
with the proximal end 106 of the cannula 102 and extends
longitudinally into the pathway 108 through an opening in the
cannula 102 to aid in the eversion of the balloon 120 and the
sleeve 110. The distal end of the elongated member 118, in some
embodiments, can be coupled to the proximal end of the balloon 120.
The proximal end of the balloon 120, in some embodiments, can be
coupled to an internal or external surface of the elongated member
118 using any coupling method known in the art so long as a
substantially fluid tight seal is established. For example, as
depicted in FIG. 1, the proximal end of the balloon 120 can be
adhered to the external surface of the elongated member 118. The
elongated member 118 can be configured to slide longitudinally
within the cannula 102 (e.g., within pathway 108) and push the
proximal end of the balloon 120 toward the distal end 104 of the
cannula 102. The elongated member 118, in some embodiments, can be
a rod, a tube, a shaft, a sheath, or any sufficiently rigid
structure extending along the longitudinal axis to allow
advancement (i.e., eversion) of the balloon 120 and sleeve 110 from
the cannula 102. In one embodiment, the elongated member 118 can be
constructed from any combination of materials enabling the
elongated member 118 to evert the balloon 120, as discussed herein.
For example, the elongated member 118 can be constructed from a
biocompatible similar to that of the cannula 102.
[0027] In some embodiments, the elongated member 118 can be
configured to limit the extent of sleeve 110 eversion and
re-inversion. By way of a non-limiting example, as the elongated
member 118 can be pushed further into the cannula 102, the sleeve
110 can begin and continue to evert out of an opening in the distal
end 104 of the cannula 102. In some embodiments, the elongated
member 118 can be configured to travel in the longitudinal
direction until it reaches a bushing or stopper (not depicted) on
the cannula 102, which will act as an eversion stop. Similarly,
pulling the elongated member 118 away from the distal end 104 can
cause sleeve 110 to re-invert into the pathway 108 of the cannula
102. In some embodiments, sleeve 110 re-eversion may be limited to
prevent tear or detachment of balloon 120 from sleeve 110 due to
undue traction exerted on balloon 120 and the sleeve 110.
[0028] In some embodiments, the cannula 102 can include a fluid
tight seal 124 configured to create a fluid tight seal between the
elongated member 118 and the opening in the proximal end 106 of the
cannula 102 that the elongated member 118 extends therethrough. The
fluid tight seal 124 can include any combination of mechanical
seals known in the art. For example, in some embodiments, the fluid
tight seal 124 can be a sliding O-ring seal (also known as a
Tuohy-Borst seal), providing on the fitting at the proximal end 106
of the cannula 102 to form a seal between elongated member 118 and
inner walls of cannula 102. In some embodiments, friction created
by the fluid tight seal 124 can act to control a rate that the
sleeve 110 can be everted and re-inverted, as controlled by the
elongated member 118. Additionally, friction can provide some
restriction to the movement of the elongated member 118 and thus
can minimize a sudden expulsion of the balloon 120 and sleeve 110
from within the cannula 102 in the presence of fluid pressure.
Although reference is made to fluid, it should be mentioned that
air, liquid, or other fluid that can be pressurized to aid in the
eversion of the balloon 120 and the sleeve 110 can be used.
[0029] Referring to FIGS. 2A-2B, in some embodiments, the sleeve
110 can be configured to extend from an inverted position within
the cannula 102 to an everted position for cell sampling the vessel
126. In particular, upon pressurization of the cannula 102 and
pressurization of the balloon 120, the sleeve 110 can be everted
partially out from the cannula 102 so that an outer surface of the
sleeve 110 can be used to capture or otherwise obtain tissue
samples. Although shown as a vessel, it should be understood that
the vessel 126 can represent any passageway or cavity that the
system 100 of the present invention can be utilized within for
sample collection. For example, the vessel 126 can be an anatomical
structure, such a vessel or cavity within a body of a subject from
which cell samples are collected.
[0030] FIG. 2A depicts an exemplary state in which the sleeve 110
is everted from inside the cannula 102. Initially, sleeve 110, and
balloon 120 are inverted within the cannula 102, as shown in FIG.
1. In the inverted position, the sleeve 110 and balloon 120 can be
inverted and folded into the cannula 102. When the cannula 102 has
been advanced to a desired location, the cannula 102 can be
pressurized to begin the everting process. In some embodiments, the
cannula 102 can be pressurized by introducing a fluid or gas into
the pathway 108 via the inflation port 122. For example, a
pressurization mechanism, such as a pump, syringe, or other device
can move fluid into and out of the cannula 102 via the inflation
port 122. Pressurization of the pathway 108 can cause the balloon
120 to pressurize and evert from within the cannula 102, for
example, through direct contact with the fluid or gas in the
pathway 108 or through a lumen in fluid communication with the
balloon 120. As would be appreciated by one skilled in the art,
pressurization the balloon 120 and its subsequent eversion can
thereby cause the sleeve 110 to partially evert from the cannula
102.
[0031] In the embodiments shown in FIG. 2A, during pressurization
of the balloon 102 and because of the partial eversion of the
sleeve 110, the end 114 of the sleeve 110 can remain inside the
inverted balloon 120, as shown in FIG. 2A, even though the balloon
120 is substantially completely everted. To accomplish the partial
eversion of the sleeve 110, the sleeve 110 can be substantially
longer than the length of the balloon 120 when the balloon 120 is
fully everted from the cannula 102. Moreover, as the balloon 120
everts, it may engage with and compress the end 114 of sleeve 110,
while pushing the end 112 of the sleeve 110 to cause sleeve 110 to
move from an inverted position to an everted position.
[0032] In some embodiments, during the eversion process, the
elongated member 118 can provide manual assistance in everting the
sleeve 110. In particular, prior to pressurizing the balloon 120,
the elongated member 118 can be at a first position, as depicted in
FIG. 1. Thereafter, the balloon 120 can be pressurized sufficiently
to stiffen the balloon 120 and allow the elongated member 118 to be
pushed forward, to evert the balloon 120. With the balloon 120
sufficiently pressurized, the elongated member 118 can be manually
pushed longitudinally from the first position to a second position
within the cannula 102. The longitudinal movement of the elongated
member 118 can push on the proximal end of the pressurized balloon
120, thus pushing the distal ends of the balloon 120 and the sleeve
110 out the distal end 104 of the cannula 102.
[0033] As discussed herein, in some embodiments, the fluid tight
seal 124 can be configured to control the rate in which the
elongated member 118 can be pushed into, and pulled out of, the
cannula 102. As the elongated member 118 moves in the longitudinal
direction toward the distal end 104 of the cannula 102, the
pressurized balloon 120 and sleeve 110 can be everted out of the
opening in the distal end 104 of the cannula 102, as shown by
arrows 202, until balloon 120 reaches a substantially fully
extended position, as shown in FIG. 2A. As the balloon 120 extends,
it may engage end 112 of sleeve 110, and act to push the sleeve 110
from an inverted position to an everted position.
[0034] When everted, either on its own or through assistance from
the elongated member 118, the balloon 120 can extend in a
substantially straight manner, as shown in FIG. 2A, to aid in
partially everting the sleeve 110 into position for sample
collection. In other words, the balloon 120, and thus the sleeve
110, may have a substantially elongated shape so that, balloon 120
everts in a substantially distal direction to aid in everting the
sleeve 110 toward a target sampling site. In some embodiments, once
everted distally, the balloon 120 can evert radially outward to
engage the inner surface of the body structure to improve sample
collection. FIG. 2A depicts the system 100 with the balloon 120 and
sleeve 110 everted out of the cannula 102 into the vessel 126
following an eversion process 202. While the sleeve 110 is in an
everted position, the surface of the everted sleeve 110 can be
configured to collect cells from the body structure to which the
sleeve 110 is adjacent. As would be appreciated by one skilled in
the art, while the sleeve 110 is in contact with the sample
collection site, a user can move the system 100 back and forth
horizontally, vertically, rotated radially, or a combination
thereof to ensure proper sample collection.
[0035] In some embodiments, to minimize advancement or retreat of
balloon 120 during eversion, the system 100, may include a coupling
mechanism (not depicted) that may act to couple a portion of the
sleeve 110 to a portion of the balloon 120. The coupling mechanism
may be designed to allow eversion of the balloon 120 while
minimizing advancement or retreat of the balloon 120 from within
sleeve 110. Of course, in some embodiments, coupling mechanism may
allow at least some axial movement of balloon 120 (e.g., during
eversion) if desired. The coupling mechanism 150 may be any
mechanism capable of securely coupling the balloon 120 and the
sleeve 110. For instance, the coupling mechanism can include any
combination of mechanisms known in the art, for example, glue,
tape, Velcro, clips, or any other commercially available mechanism.
In other embodiments, the coupling mechanism may be a mechanism
that increases friction between balloon 120 and sleeve 110. For
example, coupling mechanism may be a rough or perforated section of
balloon 120 and/or sleeve 110 that creates friction when balloon
120 is everted and pressed against sleeve 110.
[0036] The everted sleeve 110 can be used to collect cells from any
tubular structure in within the body of a subject or any cavity or
canal. This may include, for example, an artery, a vein, a urethra,
a ureter, a cystic duct, a Fallopian tube, an esophagus, small or
large bowel, the nasal cavity, a duct in the breast, etc. After the
samples have been collected on the sleeve 110, the sleeve 110 can
be re-inverted within the cannula 102 and the system 100 can be
removed for analysis or other operations.
[0037] Referring to FIG. 2B, after sample collection or other
process, the sleeve 110 can be re-inverted into the cannula 102. In
some embodiments, the elongated member 118 can be utilized to
manually assist in the inversion process 204. During the inversion
process 204, pressure may be maintained within the cannula 102
while the elongated member 118 is retracted. In particular, the
balloon 120 can be slightly depressurized to allow the balloon 120
and sleeve 110 to be pulled back into the cannula 102. The
pressure, in an embodiment, should be at a level that maintains
compression of end 114 of sleeve 110 so as the balloon is pulled
back into the cannula 102, the balloon 120 will pull the sleeve 110
with it. In some embodiments, the pressure can be at a level that
imparts structure and column strength to the balloon 120 along its
longitudinal axis to allow the reinversion of the balloon 120 to
occur. During reinversion, the sleeve 110 can be configured to move
inward without a substantial shearing motion on its surface so as
to allow the surfaces of the reinverting sleeve 110 to pinch and to
retain collected cells inside the cannula 102, as depicted in FIG.
2B. Such an inversion process can substantially prevent potential
washout of the sample during removal of the system 100 from the
sample site. Upon removal of the system 100 from the vessel 126,
the samples collected on the sleeve 110 may be washed from the
sleeve 110, recovered and analyzed. For example, upon removal of
the system 100 from a blood vessel, cells samples collected on the
sleeve 110 can be obtained using any known systems or methods
(e.g., washing) and analyzed for abnormalities such as
malignancy.
[0038] In some embodiments, a partial deflation mechanism (not
shown) may assist in partially depressurizing balloon 120 as part
of the inversion process 204. The deflation mechanism can partially
depressurize the balloon by directing fluid out of the cannula 102
through the inflation port 122 via the channel 108 or through a
lumen in fluid communication with the balloon 120. Similar to
pressurization through the inflation port 122, the partial
depressurization may be achieved using a pump, syringe, or other
device that can move fluid into and out of cannula 102 and/or the
balloon 120.
[0039] Referring to FIGS. 3A-3D, a system 300 can be provided that
includes similar components as the system 100 discussed with
respect to FIGS. 1-2B. However, as depicted in FIGS. 3A and 3B, the
sleeve 310 can be substantially shorter than the fully everted
balloon 120. However, since the sleeve 310 is substantially shorter
than the fully everted balloon 120, the sleeve 310 can also be
fully everted upon full eversion of the balloon 120, as depicted in
FIG. 3B. More specifically, referring to FIG. 3B, when the sleeve
310 can be fully everted, the end 314 of the sleeve 310 evert
distally outward from inside the cannula 102 and is not compressed
by balloon 120, similar to end 314 of sleeve 310 in FIG. 2A. Even
with the end 314 of the sleeve being free from the inside of the
cannula 102 and balloon 120, the sleeve 310 can be used to collect
samples in the same manner as discussed with respect to FIGS. 1-2B
since balloon 120 can provide pressure on the sleeve 310 when the
sleeve 310 is pressed and/or pushed against a tissue site for
sample collection. To enhance independent movement of the sleeve
310 from the balloon 120, a coupling mechanism similar to that
discussed above can be utilized.
[0040] Referring to FIG. 3C, the sleeve 310 is fully everted, it
may be difficult for the sleeve 310 to be reinverted within the
cannula 102 once the samples are collected by the surface of the
sleeve 310. In order to be protect the sleeve 310 and the sample
collected from being dislodged upon removal of the system 300 from
the sample site, the system 300 can include a protective mechanism
that can be place over the sleeve 310 during removal of the system
300 from the body.
[0041] Still referring to FIGS. 3A-3C, in some embodiments, the
system 300 can include a sheath 330 coaxially located about the
exterior of the cannula 102 that can be advanced distally over the
sleeve 310 to protect cell samples collected by sleeve 310 from
being dislodged from the sleeve 310 during withdrawal of system 300
from the collection site. FIGS. 3A and 3B illustrate the sheath 330
in a retracted position running parallel to the exterior of the
cannula 102. The sheath 330, in an embodiment, can be positioned
over the outer surface of the cannula 102 and can be configured to
advance distally along the exterior surface of the cannula 102. In
some alternative embodiments, the sheath 330 can be located within
the body of the cannula 102, or between two layers of the cannula
102 body, and slide out of the cannula 102 using any combination of
known mechanical means. The sheath 330 can be sized and dimensioned
such that when fully extended it can cover the sleeve 310 while in
a fully everted position. The sheath 330 can be constructed from
any combination of materials, for example, the sheath 330 can be
constructed from a biocompatible similar to that of the cannula
102.
[0042] To protect the sleeve 310 after sample collection, the
balloon 120 can be slightly depressurized and the sheath 330 can be
advanced distally over the sleeve 310. In some embodiments, the
balloon 120 can be configured to be depressurized by removing fluid
or gas from the cannula 102 via inflation port 122. In some
embodiments, during depressurization of the balloon 120, the
elongated member 118 can remain extended distally into the cannula
102, as shown in FIG. 3C.
[0043] Referring to FIG. 3D, in some embodiments, another mechanism
can be utilized in place of the sheath 330 to protect the everted
sleeve 310. For example, a protective sleeve 340 can be everted
over the sleeve 310. To evert the protective sleeve 340 over the
sleeve 310, the protective sleeve 340 can be acted upon via a lumen
independent of pathway 108. As would be appreciated by one skilled
in the art, the sheath 330, protective sleeve 340, and/or any other
protecting mechanism can be used in connection with the embodiments
discussed with respect to FIGS. 1, 2A, and 2B.
[0044] In other embodiments, system 300 can be designed so that a
catheter (or another device) depressurize the balloon 120 by
pushing balloon 120 aside as catheter is advanced through sleeve
310. In such a design, balloon 120 may have a tapered wall so that,
as a catheter pushes against a wall of balloon 120, it becomes
squeezed or compressed between the catheter and the inner wall of
the cannula 102. The squeezing action may depressurize the balloon
120 by pushing the fluid out of balloon 120 through the inflation
port 122. Other methods of deflating balloon 120 may also be used.
For example, if balloon 120 is no longer needed and/or disposable,
a device may be advanced into sleeve to puncture balloon 120 so
that it depressurizes.
[0045] In some embodiments, the systems 100, 300 of the present
invention can be deployed, using a gastroscope (not depicted). The
gastroscope may help guide the systems 100, 300 through the vessel
to a site of interest. In an embodiment, the gastroscope may be
provided with a body positioning designed to be situated about the
cannula 102.
[0046] In some embodiments, the systems 100, 300 can be designed to
allow a guidewire to help guide and direct sleeve 310 through the
vessel 126. For example, a guidewire can be inserted through access
port 128 in the elongated member 118 and extended through the
elongated member 118, through the pathways 108, 116 in the cannula
102 and out the distal end 104 of the cannula 102. It should be
noted that while the elongated member 118 is discussed in examples
as being a hollow structure, as would be appreciated by one skilled
in the art, the elongated member 118 can be solid depending on the
desired application. In some embodiments, then sleeve 310 can be
advanced along the length of guidewire until sleeve 310 is
positioned adjacent to a target sampling site. It should be noted
that while the guidewire can be positioned in any manner to allow
guidance of the sleeve 310, its design should minimize any
obstructions of the balloon 120 during eversion.
[0047] FIGS. 4A-4D depict example textures for use in accordance
with the sleeve 110, 310 as discussed with respect to FIGS. 1-3D.
For example, FIG. 4A depicts textured bumps, FIG. 4B depicts
zig-zagging protrusions, grooves, or ribs, FIG. 4C depicts textured
scales, and FIG. 4D depicts peaks or peaks and valleys.
[0048] Although the present invention is described with references
to examples in the medical field, the invention is not limited to
use within the medical field. The sleeve can, for instance, be can
be utilized within any type of cavity or passage, such as for
example a pipeline.
[0049] While the invention has been described in connection with
specific embodiments, it will be understood that it is capable of
further modification. Furthermore, this application is intended to
cover any variations, uses, or adaptations of the invention,
including such departures from the present disclosure as come
within known or customary practice in the art to which the
invention pertains, and as fall within the scope of the appended
claims.
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